Chronotherapy for Radiotherapy of Glioma

To Determine Whether the Timing of Radiotherapy Has an Effect on Patient Outcomes Clinical Trial

Official title:

Chronotherapy for Radiotherapy of Glioma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04735939
• Other study ID #: xhechun5
• Status: Recruiting
• Start date: February 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2021
• Source: General Hospital of Ningxia Medical University
• Contact: Hechun Xia, bachelor
• Phone: 86-951-6743983
• Email: xhechun[@]aliyun.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to determine if there is any difference in the efficacy of radiotherapy for glioma outcomes in the morning or in the evening. The study team believes that there may be a benefit to taking the radiotherapy at a certain time of day. To test this theory the study asks participants who are already taking radiotherapy for glioma consistently at either the morning or in the evening based on when they currently take their radiotherapy. There will be this study visits where the participant will be asked to fill in questionnaires related to their neurological symptoms, their sleep habits, sleep quality, survival situation, and general health information followed by a blood draw.

Description:

The objective of this study is to determine whether the timing of radiotherapy to treat glioma has an effect on patient outcomes.

Primary objective: Determine whether there is a difference in outcomes seen when patients are assigned to take their radiotherapy at either a morning time or evening time.

The Investigator hypothesize that administration time of radiotherapy during the day can affect the clinical outcomes in glioma patients.

Specific Aims Include:

• Determine whether morning vs. evening dosing radiotherapy could affect the survival time of glioma patients.

• Determine whether morning vs. evening dosing radiotherapy could affect the KPS score of glioma patients.

• Determine whether morning vs. evening dosing radiotherapy could affect the cognitive function of glioma patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age = 18 years;

2. Pathological or cytological diagnosis of glioma;

3. Normal liver and kidney function.

Exclusion Criteria:

1. Pregnant or lactating women;

2. Second primary malignancy;

3. Severe lung infection;

4. with high blood pressure although treated with medication;

5. Patients with myocardial ischemia or myocardial infarction, arrhythmia (including QT interval > 440 ms) or grade II cardiac insufficiency;

6. Arteriovenous thrombosis in 6 months prior to first administration, Such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism;

7. Serious heart, lung and bone marrow impairment;

8. History of severe hypertension or cerebral hemorrhage

Related Conditions & MeSH terms

• Glioma
• To Determine Whether the Timing of Radiotherapy Has an Effect on Patient Outcomes

Intervention

Radiation:
• radiotherapy
Determine whether there is a difference in outcomes seen when patients are assigned to take their radiotherapy at either a morning time or evening time.

Locations

Country	Name	City	State
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Ningxia Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	cognitive function of glioma patients	Determine whether morning vs. evening dosing radiotherapy could affect the cognitive function of glioma patients.	1/1/2021-31/12/2021
Primary	survival time of glioma patients	Determine whether morning vs. evening dosing radiotherapy could affect the survival time of glioma patients.	1/1/2021-31/12/2021
Secondary	KPS score of glioma patients.	Determine whether morning vs. evening dosing radiotherapy could affect the KPS score of glioma patients.	1/1/2021-31/12/2021